Competent authorities and certification bodies increasingly expect pharmaceutical and medical device companies to regularly audit their suppliers and service providers as well as their own internal organization.
Do you lack the internal expertise or availability to conduct these audits? Quality by Design offers to take on your external or internal audit program with our certified Lead Auditors or trained internal auditors.
Don’t hesitate to contact us for more information about our audit services.
Audits are an integral part of any pharmaceutical or medical device QMS. Each company needs to have an internal and supplier audit program in place.
Competent and trained auditors need to be assigned to perform the audit and write a report. QbD can perform first, second and third-party audit services for your company.
First-party audits, more commonly known as internal audits or self-inspections: ISO 9001, ISO 13485, and GMP all require a company to hold internal audits. The purpose is to check the QMS and production activities for compliance with internal procedures and with regulatory and customer requirements.
Second-party audits, also known as supplier or customer audits, are a part of the supplier management process of the QMS. In order to gain the confidence that the supplier can deliver a quality product that conforms to the company’s requirements, critical suppliers need to be regularly audited.
In order to obtain a QMS ISO certificate or a GMP/GDP license, companies are regularly inspected by regulatory and/or notified bodies. A full-system audit by an independent auditor / consultant can also be considered a third party audit.
Why do an audit?
Don’t consider audits as only a necessity. Any audit is an opportunity to gain more insights into the company itself and the quality management system.
While the purpose of an audit is to find evidence of conformity and compliance, it can be expected that gaps or non-conformities will be observed.
By defining appropriate corrective and preventive actions, it gives the company the opportunity to learn and continuously improve.
Challenges in performing an audit
- Internal auditors need to be independent from the area being audited but this can be difficult, especially in smaller companies.
- For supplier audits it is the expectation that the (lead) auditor is experienced and certified by an accredited training body.
- Internal auditors are very aware of the company’s internal procedures, but often lack knowledge of regulatory texts such as ISO standards or GMP/GDP. This can lead to tunnel vision by the internal auditor.
- Insufficient time may be allowed for internal and supplier audits, or the (lead) auditor may be given insufficient time to perform the audit. Audits then become a required “check box” rather than a means to continuously improve.
What can you expect from audit services performed by QbD?
After the initial contact with QbD’s business development team, the assigned auditor will have a short introductory meeting to make sure expectations are aligned and clear. The audit objective, scope and criteria will be defined together with the audit client.
At least one week before the audit takes place, an agenda will be shared with the audit client and auditee.
3. Audit location
The audit will take place either on-site or remotely, as requested.
4. Audit execution
During the audit the QbD auditor will take their time to make a full assessment of all topics on the agenda. The auditor will review procedures and records, will interview key personnel and will make observations during an on-site tour. They will open and close the audit by meeting with the auditee.
After the audit, the QbD auditor will write an extensive report. This report consists of an overview of the audit activities performed, their findings, as well as a clear list of non-conformities against the audit criteria and recommendations for improvement.
The follow-up of an action plan to remediate the observed non-conformities is performed by the audit client. However, upon request the QbD auditor can review the provided action plan and comment on whether the proposed actions are sufficient.
Why QbD Group?
QbD auditors have years of experience in the life science industries and have the right expertise and competencies to perform audits in the following areas:
- Pharma and biotech
- Medical devices
- Information Technology (QbD has a CISA certified auditor)
We follow your program and provide an auditor with the right knowledge. We distinguish between:
- A qualified auditor who is appropriately trained and experienced to perform internal audits. QbD can provide auditor(s) with expertise in a wide range of topics, such as qualification/validation, aseptic processing, MDSAP, etc.
- A certified lead auditor who has followed an accredited lead auditor training and has obtained the appropriate certificates. QbD can provide auditors with the following lead auditor certificates:
- ISO 19011 applied to ISO 13485
- ISO 19011 applied to GMP/GDP
Don’t hesitate to contact us so we can listen to your needs and provide you with the right audit services.